# Lutonix

- Location (FDA's records): New Hope
- FDA decisions: 2 (2014–2017): 2 original PMA approvals
- Product codes: PRC (1), ONU (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Recent decisions
- P170003: LUTONIX® 035 Drug Coated Balloon PTA Catheter, Model 9010 (Aug 25, 2017)
- P130024: Lutonix Drug Coated Balloon Pta Cateter (Oct 9, 2014)

Source page: https://510kreport.com/company/lutonix